MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M EBV AMPLIFICATION REAGENT KIT; NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV)

Model Number 09N43-095

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

Elevated complaint investigation will be initiated.

Event Description

The customer reported discrepant (false detected) alinity ebv results with lower limit of quantification (lloq).Sample id, alinity result, date, mayo result : (b)(6).Mayo results were generated using an alternative platform (roche molecular).There was no impact to patient management for the sample ids listed above.Mayo results were released to provider.The reported event was considered false detected.

Manufacturer Narrative

The ticket was reported for discrepant results (false positive) below lower limit of quantification (

• Brand Name: ALINITY M EBV AMPLIFICATION REAGENT KIT
• Type of Device: NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV)
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 16450192
• MDR Text Key: 310436415
• Report Number: 3005248192-2023-00118
• Device Sequence Number: 1
• Product Code: QLX
• UDI-Device Identifier: 00884999049505
• UDI-Public: 00884999049505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/06/2023
• Device Model Number: 09N43-095
• Device Catalogue Number: 09N43-95
• Device Lot Number: 381017
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1